Actively Recruiting
Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
Led by Henan Cancer Hospital · Updated on 2024-06-27
22
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Currently, it has been demonstrated that CDK4 is highly expressed in hepatocellular carcinoma patients and is significantly associated with poor prognosis in hepatocellular carcinoma patients. Palbociclib is the world's first marketed inhibitor of the cell cycle protein-dependent kinase CDK4/6, which is capable of blocking cell cycle progression and inhibiting tumor cell proliferation. However, current evidence for the use of CDK4/6 inhibitors in patients with advanced hepatocellular carcinoma cells remains lacking. This study used palbociclib backline treatment for patients with advanced hepatocellular carcinoma, aiming to further validate the potential role of CDK4/6 inhibitors in the treatment of patients with advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- ECOG performance status score of 0 to 2
- Histologically or cytologically confirmed unresectable advanced hepatocellular carcinoma
- Failed or intolerant to at least second-line treatment
- Expected survival of 3 months or more
- At least one evaluable lesion within 21 days prior to enrollment based on RECIST 1.1 criteria
- Barcelona Clinical Liver Cancer stage B or C, unsuitable for surgery or local treatment, or progression after such treatments
- Child-Pugh liver function class A or B (score 7 or less)
- Hepatitis B virus DNA below 500 IU/ml or 2500 copies/ml and on at least 2 weeks of antiviral treatment before study entry; hepatitis C virus RNA positive patients must have completed antiviral treatment at least 1 month before study entry
- Central nervous system metastases without symptoms or with symptoms controlled and stable for at least 4 weeks after treatment
- Blood tests meeting specified criteria: ANC ≥1.0×10⁹/L, platelets ≥50×10⁹/L, hemoglobin ≥80 g/L
- Biochemical tests meeting specified limits: total bilirubin ≤3 times upper normal limit, ALT and AST ≤5 times upper normal limit, serum creatinine ≤1.5 times upper normal limit or creatinine clearance >50 ml/min
- Coagulation tests within limits: prothrombin time ≤1.5 x upper normal limit, aPTT ≤1.5 x upper normal limit
- Cardiac function: left ventricular ejection fraction ≥55%, ECG QTc <450 ms for men, <470 ms for women
- Agree to abstain from sex or use effective contraception during treatment and for at least 7 months after last dose
- Signed informed consent
You will not qualify if you...
- Prior treatment with any CDK4/6 inhibitor
- Antitumor therapy in another clinical trial within 4 weeks before enrollment
- Major surgery within 4 weeks before enrollment or incomplete recovery from such surgery
- Severe heart disease or discomfort
- Co-infection with hepatitis B and hepatitis C or hepatitis D
- Allergy to the drug perphenazine or its components
- Other cancers within the past 5 years except certain cured skin or in situ cancers
- Conditions impairing oral drug administration such as swallowing difficulties, gastrointestinal resection, chronic diarrhea, or intestinal obstruction
- Pregnant or breastfeeding women, women of childbearing potential with positive pregnancy test, or unwilling to use effective contraception during and for 7 months after the study
- Severe other diseases or conditions that would interfere with treatment or make participation unsuitable according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
H
Hao Zhuang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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